Ocular implant and methods for making and using same

Abstract

An ocular implant device that is insertable into either the anterior or posterior chamber of the eye to drain aqueous humor and / or to introduce medications. The implant can include a substantially cylindrical body with a channel member that regulates the flow rate of aqueous humor from the anterior chamber or introduces medications into the posterior chamber, and simultaneously minimizes the ingress of microorganisms into the eye.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation-in-part of U.S. patent application Ser. No. 10 / 182,833, filed Dec. 27, 2002, which is the national stage of International Application No. PCT / US01 / 00350, filed Jan. 5, 2001, which claims the benefit of U.S. provisional patent application Ser. No. 60 / 175,658, filed Jan. 12, 2000, the entire content of each being incorporated herein by reference. International Application No. PCT / US01 / 00350 was published under PCT Article 21(2) in English.FIELD OF THE INVENTION [0002] The present invention relates to an ocular implant and more particularly, a filtered and / or flow restricting ocular implant for use through the cornea of an eye to relieve intraocular pressure, and for use through the sclera to introduce medications into the posterior chamber of the eye. In doing so, the embodiments of the present invention are applicable for both transcorneal and transscleral applications. BACKGROUND OF THE INVENTION [0003...

AI Technical Summary

Benefits of technology

[0011] It is therefore an object of the present invention to provide a device and method that may be used to relieve IOP by draining the anterior chamber of the eye of aqueous humor fluid in a controlled manner.

[0013] It is yet another object of the present invention to provide a device and method that may be used as an implant having a size, shape and composition suitable for various applications, and including one or more filters, valves or restrictors to configure a desired response provided by the implant.

[0014] These and other objects are substantially achieved by providing an implant that is insertable through the clear cornea of the eye into the anterior chamber to drain aqueous humor, or similarly insertable through the sclera to introduce medications into the posterior chamber of the eye. The implant may include a substantially cylindrical body having one or more channels that permits drainage of aqueous humor from the anterior chamber to the external surface of the clear cornea, or permits substance release into the posterior chamber of the eye. The implant may further include a head that rests against an outer surface of the clear cornea or sclera, a foot that rests against an inner surface of the cornea or sclera, and one or more elongated filter members retainable within the channel of the body to regulate the flow rate of aqueous humor, introduce medications, and minimize the ingress of microorganisms.

Problems solved by technology

A major symptom of glaucoma is a high intraocular pressure, or “IOP”, which is caused by the trabecular meshwork failing to drain enough aqueous humor fluid from within the eye.

These procedures are very labor intensive for the surgeons and are often subject to failure due to scaring and cyst formations.

Another problem often related to the treatments described above includes drug delivery.

Currently there is no efficient and effective way to deliver drugs to the eye.

Drops are a very inefficient way of delivering drugs and much of the drug never reaches the inside of the eye.

Drugs may be injected into the eye, however, this is often traumatic and the eye typically needs to be injected on a regular basis.

PCT / US01 / 00350 above, however, existing shunts are also subject to numerous difficulties.

The first problem associated with shunt use is the regulation of aqueous outflow.

This problem typically results because the drainage rate of the fluid depends substantially on the mechanical characteristics of the implant until there has been sufficient wound healing to restrict fluid outflow biologically.

Effective balancing of biological and mechanical resistance to aqueous humor outflow remains a problem for implant-based drainage procedures.

Each of these mechanisms, however, may become a liability once wound healing has been established.

Restrictive elements within the implant, when combined with the restriction effected by wound healing, may inordinately reduce the rate of aqueous humor outflow possibly to non-therapeutic levels.

The second problem associated with existing shunt use is the possibility of intraocular infection.

Unfortunately, the presence of an implant provides a conduit through which bacteria can gain entry to the anterior chamber, thereby resulting in intraocular infections.

Certain drainage devices have introduced filters, valves or other conduit systems which serve to impede the transmission of infection into the anterior chamber, however, these mechanisms have limitations.

Even when effective in resisting the transit of microorganisms, they have hydraulic effects on fluid outflow that may also impair effective drainage.

Finally, a problem of local tissue tolerance arises with existing devices because the implant, as a foreign body, may incite tissue reactions culminating in local inflammation or extrusion.

This may be perceptible or uncomfortable for the patient, and these reactions to the presence of the implant may make its use clinically unsuitable.

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